There are many eQMS platforms out there that have been helping medical device developers bring their products to market for decades. But which software offers the best value and support for an innovative and growing business?
First, let’s start with some key questions:
eQMS platforms differ in price tag, levels of customer support and the way they package up and interconnect their tools to help clients meet their quality and compliance goals.
But at the heart of every offering should be the tools you need for:
But the way you access and build out these quality functions within each eQMS can be very different.
Some platforms will tie you to their way of working almost completely, using pre-set quality structures to help you meet ISO standards and FDA regulations. However, many customers find these incredibly restrictive, as they have to change their processes entirely to fit in with the software.
Some platforms even require you to shift your documentation into their native eQMS format in order to work with them, rather than simply migrate existing Word and Excel documents into their document structures. That’s a lot of effort and will make it hard to extract yourself from their system if you need to leave.
Starting with some of these heavy-duty eQMS may take several months and require extensive internal re-training, which can really affect the pace of your development.
Most eQMS platforms will offer different tiers of access depending on your company’s level of maturity. These might include start-up, scaling and enterprise packages with different levels of functionality and cost involved.
Depending on which company you work you may find yourself having to pay unexpected extra costs as you grow. You may have to buy more seats or pay for vital modules that weren’t included in your original package.
The level of support you will receive to configure and shape your system will also vary depending on the size of your organisation and much you are prepared to pay.
So, let’s look at 5 major eQMS platforms that medical device developers use around the world, to see if they will fit with your requirements.
And as an extra measure, let’s compare all those with ‘Doing it Yourself’ using SharePoint.
Established in 1993 and headquartered in Salt Lake City, Utah, MasterControl has grown into a globally recognised leader in eQMS solutions for the life sciences industry. With over 1,000 clients worldwide, including some of the largest names in pharmaceuticals, biotechnology, and medical devices, MasterControl provides powerful tools for managing compliance, document control, audits, and training. Known for its robust feature set, it is designed to meet the demands of highly regulated industries but can be overly complex for smaller, more agile businesses.
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Founded in 2015 in Dublin, Ireland, Qualio was created to address the quality management needs of life sciences companies, particularly those navigating complex regulatory environments. With its headquarters now located in San Francisco, California, Qualio has grown to serve organisations globally, offering an accessible, cloud-based platform designed to help businesses streamline their quality processes. Qualio's stated mission is to break down the silos of development, manufacturing, and quality, helping life-science companies collaborate more effectively.
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Founded in 2013 and headquartered in Indianapolis, Indiana, Greenlight Guru is a purpose-built quality management software platform exclusively designed for medical device companies. By focusing on the unique needs of this industry, Greenlight Guru has developed an end-to-end solution that supports every stage of the product lifecycle, from design and development to post-market surveillance, ensuring compliance with stringent standards and regulations, including ISO 13485 and FDA 21 CFR Part 820.
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Developed by Ideagen, Q-Pulse is a robust quality management software solution designed to serve highly regulated industries, including aviation, life sciences, healthcare, manufacturing, and utilities. First introduced in the 1990s and headquartered in Nottingham, UK, Q-Pulse has become a trusted tool for organisations seeking to manage compliance, risk, and operational quality efficiently. Its modular approach allows different kinds of businesses to tailor the platform to their unique needs, offering a comprehensive suite of tools for document control, audit management, corrective actions, and more.
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Founded in 2008 and headquartered in Cambridge, UK, Cognidox is an eQMS platform with a lean approach to design controls and quality, tailored for technology and innovation-driven industries.
It is designed to simplify med-tech compliance, enhance collaboration, and accelerate product development by centralising document control and quality processes. Cognidox was originally developed to support high-tech companies but has been widely adopted in the med-tech sector.
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Developed by Microsoft, SharePoint is a popular document management and collaboration tool. While not a dedicated eQMS, it is often adopted by organisations for quality management needs.
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There’s no right answer to this question because every company’s needs are different. However, some eQMS companies are more suited to support scaling enterprises than others. If you are an innovative SME looking to shift quickly from paper or Google Docs to a digital platform, you should look for a solution that can be effectively right-sized to the way you work.
Using a proprietary eQMS platform is a good idea, compared to the effort of building a bespoke system with SharePoint - but you should beware the cost and complexity of using platforms built for larger enterprises if you are in growth mode.
Make sure your chosen system can scale with your needs and that you won’t be charged a fortune for features you’re not using